The clinical development of new innovative drug products, its ethical aspects, regulations and quality assurance and monitoring of trial and understanding the steps are covered here. You will follow an intensive program and collaborate with other students.

A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP). The main area of work of a clinical research associate is to monitor clinical trials. He or she will work directly with the parent company of a clinical trial, as an independent or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences or Medical science and a certification from a good Clinical research training organization and needs to have a good knowledge of Good clinical practice and local regulations.

This program includes various lectures and insights into patient dossier monitoring, which belongs to the core business of a CRA, a clinical research associate. The program also includes role plays, debates and workshops, which will lead to better understanding of the ins and outs of the pharmaceutical industry in general and clinical drug development in particular.

Programs in clinical trials management Available as nearly 1 semester evening and Weekend course with lectures held depending on the slot selected and include courses on:

• Clinical trial lifecycle
• Clinical study design
• Clinical research methodologies
• Regulatory issues
• Biostatistics

Eligibility:

Applicant should have a minimum of Graduation or Postgraduation in Biotechnology / Botany / Zoology / Chemistry/ Life Sciences / Microbiology / Biotechnology / Biochemistry / Pharmacy / Medicine / Nursing / Physiotherapy / Dentistry / Ayurveda / Homeopathy and Veterinary Science.

Popular Career Options

Prospective employers generally require job candidates to have 2-5 years of experience in assisting with clinical trials in order to obtain the appropriate experience necessary for the clinical data manager role. Specific skills include the development of electronic case report forms, data management plans, data review and reconciliation. The ability to work on a team and to provide leadership to support personnel is also important.